EUCTR2021-003409-23-PL进行中（未招募）1 期
Application of antiCD19 CAR T lymphocytes for the treatment of adult patients with B-cell acute lymphoblastic leukemia. Phase I/II clinical trial (MERMAID1)
Medical University of Warsaw0 个研究点目标入组 20 人开始时间: 2023年5月31日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Diagnosis of B-ALL Ph (-) with confirmed expression of CD19 molecules in> 90% of neoplastic cells after resistance / relapse;
- •2. Primary refractory disease, i.e. complete remission (CR or CRi) has not been achieved after 2 cycles of induction chemotherapy or
- •3. Recurrent disease - when:
- •A. complete remission was achieved, but the disease relapsed (> 5% B-ALL lymphoblasts in the bone marrow)
- •B. complete remission of MRD (+) was achieved, but after at least 2 chemotherapy cycles (counting from the start of treatment) MRD progressed (cytometric method) by min. 1 log in 2 consecutive bone marrow biopsies taken at an interval of min. 2 weeks;
- •4. Age 18-65 years on screening date;
- •5. Performance status assessed in the ECOG (Eastern Cooperative Oncology Group) scale of = 2,
- •6. Satisfactory organ function during screening:
- •A. ALT / AST activity <2.5 x Upper Limit of Normal (ULN) and total bilirubin <1.5 mg / dL (<4 mg / dL in patients with Gilbert's syndrome);
- •B. Ejection fraction (EF)> 40% confirmed by ECHO, with no significant pericardial effusion within 6 weeks prior to screening;
- •C. Respiratory capacity: arterial blood saturation> 92% without oxygen therapy, no significant pleural effusion;
- •D. Creatinine clearance> 30 ml / min;
- •7. Negative test results for HIV, HBV (HBs-) and HCV (anti-HCV-);
- •8. Understanding and giving informed consent to participate in the study,
- •9. Negative pregnancy test (serum) in women of childbearing age;
- •10. Declaration of the use of an appropriate method of contraception after signing the informed consent form up to 6 months from the use of CAR T therapy;
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Diagnosis of B-cell lymphoblastic lymphoma (presence of <20% leukemic blasts in blood or bone marrow at diagnosis);
- •2. Isolated central nervous system (CNS) relapse;
- •3. History of significant diseases of the central nervous system (CNS) or significant current CNS disorders (seizures, paralysis, aphasia, CNS ischemia / hemorrhage, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, psychosis and diseases associated with incoordination or movement disorders);
- •4. The need for systemic immunosuppressive therapy;
- •5. Allogeneic hematopoietic cells (alloHCT) transplant surgery in less than 3 months prior to screening;
- •6. Presence of Philadelphia chromosome in cytogenetic test or BCR-ABL transcript in FISH or molecular test;
- •7. Concurrent presence of another neoplasm and another neoplasm diagnosed up to 2 years prior to study enrollment;
- •8. Active bacterial, viral or fungal infections, including SARS-CoV2;
- •9. Latent infections with HCV, HBV, HIV;
- •10. Other co-morbidities that have been assessed as likely to interfere with the conduct of the study, as assessed by the investigator;
- •11. Pregnancy;
- •12. Nursing women or women of childbearing age or men who do not consent to the use of an effective method of contraception while participating in the study;
- •13. Inability to give informed consent to participate in a study.
研究者
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